Feasibility Study for Training Pump Naïve Subjects To Use The Paradigm® System And Evaluate Effectiveness

Completed · Phase 4

Conditions studied: Type 1 Diabetes

In brief

Feasibility study to compare the effectiveness of the Paradigm Sensor Augmented System versus subjects continuing to administer insulin in multiple dose injections. Evaluate the educational materials and time required for training subjects naïve to continuous subcutaneous insulin infusion (CSII) to use the Paradigm 722 REAL Time System in preparation for a large multi-center clinical trial

Key facts

Study ID

NCT00530023

Run by

Medtronic MiniMed, Inc.

People needed

29

Starts

2006-02-01

Expected to finish

2006-09-01

Last updated by the study team

2011-06-10

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is between 18 - 70 years of age (inclusive)
• Subject is diagnosed with Type 1 Diabetes Mellitus as determined by the Investigator.
• Diabetes is diagnosed > (greater or equal to) six (6) months prior to study entry.
• A1C > 7.5% (greater than or equal to) as measured by the Central Laboratory at Screening Visit 1.
• Subject currently requires insulin administration by injection > (greater or equal to) three (3) times daily.
• Subject is currently (over past 3 months) performing an average of four (4) blood glucose measurements per day, as determined and documented by the investigator
• Subject has been treated in the investigator's practice or in a referring endocrinologist's practice for at least 6 months prior to the study
• Subject is fluent in speaking, understanding, and reading English.
• Subject is able and willing to perform the study procedures and agrees to wear sensors at least five (5) days per week (722 Arm only) during the study period.
• Subject is able to use the study devices (722 Arm only) as labeled
• Subject has reviewed and signed the Informed consent, HIPPA Authorization, and California Experimental Subject's Bill of Rights (California only).
• Subject has the capability to upload their insulin pumps or glucose meters every two weeks; access to the Internet and specific computer system requirements are necessary to participate in the study

You may not qualify if…

• Subject is pregnant or planning to become pregnant during the course of the study.
• Subject has a history of tape allergies that have not been resolved.
• Subject self-reports any skin abnormality (i.e. psoriasis, rash, and staphylococcus infection).
• Subject has any additional condition(s) (medical, social, or psychosocial) that in the Investigator's opinion would warrant exclusion from the study or prevent the subject from completing or complying with the study requirements.
• Subject is currently or within past 4 weeks participated in an investigational study (drug or device).
• Subject has a history of tape allergies that have not been resolved.

Where it is running

• Diabetes Treatment Center, Loma Linda University — Loma Linda, California, United States
• Portland Diabetes & Endocrinology — Portland, Oregon, United States

Full record on ClinicalTrials.gov

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